Laparoscopic lead implantation method

• US 9,925,367 B2
• Filed: 11/20/2014
• Issued: 03/27/2018
• Est. Priority Date: 09/02/2011
• Status: Active Grant

• Current Assignee: Paras Holdings LLC
• Original Assignee: EndoStim, Inc.
• Inventors: Sharma, Virender K., Policker, Shai, Goode, Paul V., Glasberg, Ofer
• Primary Examiner(s): Stice, Paula J
• Application Number:
  US14/548,855
• Publication Number:
  US 20150119646A1
• Time in Patent Office: 1,223 Days
• CPC Class Codes: A61B 1/3132 for laparoscopy
• CPC Class Codes: A61B 17/0401 Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811
• CPC Class Codes: A61B 2017/00818 Treatment of the gastro-intestinal system
• CPC Class Codes: A61B 2017/00827 Treatment of gastro-esophageal reflux
• CPC Class Codes: A61B 2017/0417 T-fasteners
• CPC Class Codes: A61N 1/0509 Stomach and intestinal electrodes
• CPC Class Codes: A61N 1/0517 Esophageal electrodes

Abstract

A method of laparoscopically implanting an electrically stimulating lead proximate the lower esophageal sphincter (LES) of a patient includes delivering the lead through a port of a laparoscope inserted into the abdominal cavity of the patient through an incision in the abdominal wall. The stimulating electrode is implanted in or proximate the muscularis layer of the lower esophageal wall to treat esophageal reflux disease (GERD). The lead includes a needle and suture at its distal end for pulling the electrode into the muscular wall of the LES. Clips are applied to the suture attached to the distal end of the lead to prevent retrograde movement of the electrode. The lead also includes an anchoring member for anchoring the portion of the lead proximal to the electrode. The method and lead used with the method allow the surgeon to work within the confined anatomy present at the gastroesophageal junction and prevents backwards movement and dislodgment of the electrode. The implantation procedure can be combined with a hiatal hernia repair to repair the hernia and prevent recurrence of a hiatal hernia.

Claims

1. A method of laparoscopically implanting at least one electrically conductive electrode, as part of an electrically conductive lead, proximate the lower esophageal sphincter (LES) of a patient, said method comprising the steps of:

inserting the distal end of a laparoscope into an abdominal cavity of a patient through an incision in an abdominal wall of said patient;

surgically exposing at least 2 cm of an anterior abdominal portion of a lower esophageal wall of said patient;

delivering said electrically conductive lead through a port on said laparoscope, wherein said lead comprises an elongate metal body having a proximal end and a distal end, said elongate body being covered in an electrically insulating material, said proximal end having a connector for connection to an implantable pulse generator and said distal end including said at least one exposed electrode and an anchoring member, said lead further comprising a first suture having a first end and a second end opposite said first end, wherein said first end is attached to said distal end of said lead body and a first needle is attached to said second end;

advancing said electrically conductive lead to a target position at an anterior surface of said exposed lower esophageal wall;

using said first needle and said first suture to pass said electrode through said LES such that said exposed electrode comes to rest within or proximate a muscular layer of a wall of said LES and said first needle and a portion of said second end of said first suture re-emerge from said wall of said LES;

applying at least one securing member to said portion of said second end of said suture at a distance at least 2-15 mm away from said wall of said LES;

removing said first needle and excess first suture; and

,

fixing said anchoring member to proximate LES tissue by using a separate second needle to couple a second suture to said anchoring member.

2. The method of claim 1, wherein said at least one securing member comprises any one of a clip, suture, u-clip, or anchor.

3. The method of claim 1, wherein said at least one anchoring member comprises a butterfly tab having at least one opening and said step of coupling said second suture to said anchoring member comprises passing said second suture through said at least one opening.

4. The method of claim 1, wherein said at least one anchoring member comprises a suture sleeve having at least one groove and said step of coupling said second suture to said anchoring member comprises passing said second suture around said at least one groove.

5. The method of claim 1, wherein said first suture comprises a barbed micro-architecture of a suture.

6. The method of claim 1, further comprising the steps of repeating the steps of surgically exposing at least 2 cm of an anterior abdominal portion of a lower esophageal wall of said patient through fixing said anchoring member to proximate LES tissue by using a separate second needle to couple a second suture to said anchoring member to implant additional electrically stimulating leads.

7. The method of claim 1, further comprising the step of using an external device to assess the impedance between each electrode to ensure accurate positioning of the electrodes within the muscularis layer of the lower esophageal wall.

8. The method of claim 1, further comprising the step of endoscopically illuminating the lower esophageal sphincter to identify the appropriate location for dissection and placement of said at least one electrode.

9. The method of claim 1, further comprising the step of endoscopically assessing lead placement to rule out perforation of said lower esophageal wall.

10. The method of claim 9, further comprising the step of repositioning said lead if perforation of said lower esophageal wall has occurred.

11. The method of claim 1, wherein said implantation is combined with a hiatal hernia repair procedure to repair a hiatal hernia and prevent recurrence of a hiatal hernia in said patient.

12. The method of claim 1, further comprising the steps of:

exposing a diaphragmatic crura of said patient; and

,

applying at least one suture to said diaphragmatic crura.

13. The method of claim 1, further comprising the step of attaching said proximal end of said lead to an implanted pulse generator.

14. The method of claim 1, wherein said implanted lead is used to treat esophageal disorders such as gastroesophageal reflux disease (GERD), achalasia, and esophageal dysmotility.